ES2863779T3 - Intravascular catheter having an extendable incision portion and grating instrument - Google Patents

Abstract

An intravascular catheter device (10) for treating an area of care located within a blood vessel (50) comprising atherosclerotic material (54), said device (10) comprising: a tube (30, 130, 230, 330) of flexible catheter; a handle assembly (20), wherein the flexible catheter tube (30, 130, 230, 330) extends from the handle assembly (20); an expandable portion (32, 132, 232, 332) secured to a distal end of said catheter tube (30, 130, 230, 330) and comprising a plurality of struts (34A, 34B, 134A, 134B, 134C, 134D , 234A, 234B, 334A, 334B) each defining an outward-facing surface, the expandable portion (32, 132, 232, 332) being operable between a closed position, wherein the portion (32, 132, 232, 332) expandable has a first diameter and an open position, wherein the expandable portion (32, 132, 232, 332) has a second diameter that is greater than the first diameter; an inner sleeve (40, 140, 240, 340) traveling through the flexible catheter tube (30, 130, 230, 330) and in communication with the handle assembly (20), wherein the sleeve (40, 140, 240, 340) interior is configured to move the expandable portion (32, 132, 232, 332) between the open and closed positions; a grating instrument (144, 244, 344) located on at least one of the struts (34A, 34B, 134A, 134B, 134C, 134D, 234A, 234B, 334A, 334B), wherein said grating instrument (144 , 244, 344) comprises a series of grid openings and is configured to remove atherosclerotic material (54) when the expandable portion (32, 132, 232, 332) is placed in the open position and moved axially through the vessel ( 50) blood; an embolic protection device (90) located and configured to surround at least a portion of the outer surface of the expandable portion (32, 132, 232, 332) when the expandable portion (32, 132, 232, 332) is located both in the open as well as the closed position, in which the embolic protection device (90) is configured to capture the fragments of the grated atherosclerotic material (54) by the grating instrument (144, 244, 344); and an incision member (36, 136, 236, 336) provided with and extending from the outward facing surface of at least one of the struts (34A, 34B, 134A, 134B, 134C, 134D, 234A, 234B, 334A , 334B), the scoring member (36, 136, 236, 336) has a sharp edge located along an upper edge thereof in which said sharp edge extends substantially parallel to a longitudinal axis of the portion ( 32, 132, 232, 332) expandable when the expandable portion (32, 132, 232, 332) is in the closed position and is configured to mark atherosclerotic material (54) as it moves axially through the blood vessel (50).

Description

DESCRIPTION

Intravascular catheter having an extendable incision portion and grating instrument

Cross reference to related applications

This application is a continuation in part of Application No. 15 / 200,767 filed on July 1, 2016 and published as US2016 / 0310163 A1, which is a continuation in part of Application No. 13 / 613,914 filed on September 13, 2012 and published as US2013 / 0066346, claiming the benefit of United States Provisional Application No. 61 / 534,018, filed on September 13, 2011.

Background of the invention

This invention relates generally to intravascular catheters, such as those that can be used during minimally invasive surgical procedures. In particular, this invention relates to an intravascular catheter having an expandable incision portion.

Atherosclerosis is a chronic disease in which atheroma plaque builds up on the inner walls of a blood vessel. As a result, the walls of the blood vessels can become inflamed and, over time, can harden to form atherosclerotic lesions that cause a narrowing of the lumen of the vessel. In severe cases, atherosclerotic lesions can rupture and induce the formation of thrombi (ie, blood clots), which can impede blood flow through the narrowed vessel lumen.

There are known procedures and devices to treat or otherwise reduce the risks associated with atherosclerosis, such as angioplasty. However, in some cases it would be desirable to fragment the atherosclerotic lesions. Thus, it would be desirable to provide an intravascular catheter having an expandable portion that can be selectively controlled by a user and adapted to create incisions in atherosclerotic material to facilitate fragmentation of the material during an angioplasty procedure.

There are known methods and devices for performing atherectomy by scraping atherosclerotic tissue using a high-speed rotational motion. These devices include the Diamondback 360® from Cardiovascular Systems, Inc..1 and the Rotablator ™ from Boston Scientific ™ 2. These devices are complex and require high-speed motors and control systems to operate the motors. In some cases, it would be desirable to remove the atherosclerotic material by grating or peeling off by axial movement. Therefore, it would be desirable to provide an intravascular catheter that has an expandable portion and also has a surface of a grating instrument to remove atherosclerotic material by axial movement back and forth through the blood vessel.

1 http://www.csi360.com/products/coronary-diamondback-360-coronary-orbital-atherectomy-systemcrowns/

1 http://www.bostonscientific.com/en-US/products/plaque-modification/rotablator-rotational-atherectomy-system.html

Stroke is a risk that is sometimes associated with surgical procedures such as the treatment of peripheral arterial disease. Plaque fragments, clots, or other particles can break off and travel through the patent's vascular system and cause damage. As such, embolic protection devices are sometimes placed in the patient's vascular system during surgical procedures to trap and remove emboli that may form or dislodge. The use of such devices generally requires the selection, insertion, positioning, and removal of a separate device. Proper design, inventory maintenance, selection, placement, and removal can be difficult, especially in light of the patient's anatomy, conditions, and treatments. Additionally, devices in place can be cumbersome and difficult to avoid. Therefore, it would be desirable to provide an intravascular catheter that has an expandable portion and also has an integrated embolic protection device.

US5074871 discloses a catheter atherotome and method for use to perform a partial atherectomy on an artery and thus enlarge the lumen effectively available for blood flow through the artery. An expandable cutter head at the distal end of a catheter includes several elongated flexible members mounted in a parallel matrix and angularly spaced from each other around the associated ends of two concentric members of the catheter such that relative longitudinal and rotational movement of the members The catheter selectively bows the flexible members arcuately outward into a cut position or places them in alignment parallel to the catheter.

US5100425 discloses an expandable transluminal atherectomy catheter having forwardly directed cutting means (24) at the end of a catheter (22) that can be inserted into the artery in the vicinity of the stenosis along a wire ( 32) guide. During insertion, the cutting means (24) is collapsed by an outer sleeve (40) which can be retracted after insertion to allow the cutting means to expand to fill the artery.

WO2016210167 discloses a tissue removal catheter including a transmission shaft (12) and a tissue removal head (14). The tissue removal head is at the distal end of the drive shaft and is configured to rotate about a longitudinal axis of the drive shaft.

WO 2015/195606 A1 discloses an intravascular catheter device comprising an expandable portion with incision elements therein.

Summary of the invention

The invention is defined by the independent claim and the preferred embodiments are listed in the dependent claims.

This invention relates to an intravascular catheter device for use during a surgical procedure. The catheter device includes a catheter tube having an expandable portion with a plurality of struts each defining an outer surface. The expandable part can be operated between a closed position, in which the expandable part has a first diameter, and an open position, in which the expandable part has a second diameter that is larger than the first diameter.

The grating instruments are integrated with the struts. In exemplary embodiments, the grating instruments may comprise slightly or partially raised openings, which may further comprise a sharp portion. The grating instruments can be configured to grate or peel atherosclerotic material when the expandable portion is moved axially back and forth through the blood vessel. An incision element is also provided on the outer surface of one or more of the struts. The incision element can be configured to fragment the atherosclerotic plaque.

An embolic protection device is integrated with the expandable part. In exemplary embodiments, the embolic protection device is a mesh or film placed over a portion of the struts that is configured and positioned to trap atherosclerotic material that is grating or peeling off.

Various aspects of this invention will be apparent to those skilled in the art from the following detailed description of the preferred embodiments, when read in light of the accompanying drawings.

Brief description of the drawings

Figure 1 is a plan view of a catheter device including a handle assembly and a catheter tube having an expandable incision portion, in accordance with a first embodiment of this invention.

Figure 2 is a cross-sectional side view of the handle assembly taken along section line 2 2 shown in Figure 1 when the catheter device is in a first mode of operation.

Figure 3 is an enlarged cross-sectional side view of the catheter tube taken along section line 3-3 shown in Figure 1 illustrating the expandable incision portion disposed within a blood vessel.

Figure 4 is a cross-sectional end view of the expandable incision portion taken along section line 4-4 shown in Figure 3.

Figure 5 is a cross-sectional side view of the handle assembly taken along section line 2 2 shown in Figure 1 when the catheter device is in a second mode of operation.

Figure 6 is an enlarged cross-sectional side view of the catheter tube taken along section line 3-3 shown in Figure 1 illustrating the expandable incision portion in an open position.

Figure 7 is a cross-sectional end view of the expandable incision portion taken along section line 7-7 shown in Figure 6.

Figure 8 is an enlarged side view of a catheter tube having an expandable incision portion, in accordance with a second embodiment of this invention.

Figure 9 is a side view of the catheter tube shown in Figure 8 illustrating the expandable incision portion in an open position.

Figure 10 is a cross-sectional end view of the expandable incision portion taken along section line 10-10 shown in Figure 9.

Figure 11 is an enlarged side view of a catheter tube having an expandable incision portion.

Figure 12 is a side view of the catheter tube shown in Figure 11 illustrating the expandable incision portion in an open position.

Figure 13 is an end view of the catheter tube as shown in Figure 12.

Figure 14 is an enlarged side view of a catheter tube having an expandable incision portion.

Figure 15 is a side view of the catheter tube shown in Figure 14 illustrating the expandable incision portion in an open position.

Figure 16 is an end view of the catheter tube as shown in Figure 15.

Figure 17 is a side view of the device shown in Figure 8 with an exemplary embolic protection device installed therein.

Figure 18 is a side view of the device shown in Figure 17 with the expandable incision portion in the open position.

Figure 19 is a side view of the device shown in Figure 11 with the exemplary embolic protection device installed therein.

Figure 20 is a side view of the device shown in Figure 19 with the expandable incision portion in the open position.

Figure 21 is a side view of the device shown in Figure 11 with another example of an embolic protection device installed therein.

Figure 22 is a side view of the device shown in Figure 21 with the expandable incision portion in the open position.

Figure 23 is a side view of another exemplary embodiment of the device of Figure 8.

Figure 24 is a side view of the device of Figure 23 illustrated in an open position.

Figure 25 is a side view of another exemplary embodiment of the device of Figure 11.

Figure 26 is a side view of the device of Figure 25 illustrated in an open position.

Figure 27 is a side view of another exemplary embodiment of the device of Figure 14.

Figure 28 is a side view of the device of Figure 27 illustrated in an open position.

Figure 29 is a side view of an embodiment according to the invention of the device of Figure 8.

Figure 30 is a side view of the device of Figure 29.

Detailed description of the preferred embodiments

Referring now to the drawings, a catheter device, generally indicated 10, in accordance with this invention is illustrated in Figure 1. The illustrated catheter device 10 is configured to treat or reduce the risks associated with atherosclerosis. In general, catheter device 10 includes an expandable incision portion that can be inserted into a blood vessel and expanded to create incisions in atherosclerotic material that has accumulated on the inner walls of the blood vessel. The incisions facilitate the fragmentation of atherosclerotic material during a posterior angioplasty or atherectomy procedure. Although catheter device 10 will be described and illustrated in the context of treating atherosclerosis, it should be appreciated that catheter device 10 can be used in any desired environment and for any desired purpose.

Referring now to Figures 1 and 2, the illustrated catheter device 10 includes a handle assembly, generally indicated 20. The illustrated handle assembly 20 includes an elongated cylindrical handle body 21. The handle body 21 may alternatively have any other shape that is suitable for easy handling by a surgeon. In addition, the handle body 21 can be made of any suitable rigid material including, but not limited to, stainless steel or polymers.

As shown in Figure 2, the illustrated handle body 21 defines an internal chamber 22. A passage 23 extends into an end portion of the body 21 of the handle to communicate with the internal chamber 22. Handle body 21 further includes a slot 24 that extends through a side wall thereof to communicate with internal chamber 22. The illustrated slot 24 can be of any length or width as desired. As shown in Figure 1, an indicator 24A may be provided on the handle body 21 adjacent to the slot 24. For example, the indicator 24A may be a visual scale or any other indicating means, the purpose of which will be explained below.

The illustrated handle assembly 20 also includes a control member 25 that is supported on the handle body 21 for sliding movement within the slot 24. For example, the control member 25 can be moved between a forward position (shown in Figure 2), a rearward position (shown in Figure 5) or any intermediate position, which will be explained in more detail below. As shown in Figure 2, the illustrated control member 25 includes a base portion 26 that is disposed within the internal chamber 22 of the handle body 21. The base portion 26 may define an outer cross-sectional shape that generally corresponds to a cross-sectional shape of the inner chamber 22, although this is not necessary. Alternatively (or in addition), control member 25 may be movably supported on handle body 21 by bearing, bushing, guide rail, or any other structural means. In other embodiments, the control member 25 may be supported for rotational movement, pivoting movement, or any other type of movement with respect to the body 21 of the handle, the purpose of which will become apparent below. The visual indicator 24A, described above, is configured to identify the relative position of the control member 25 with respect to the body 21 of the handle.

The illustrated handle assembly 20 also includes a locking mechanism 27 that is configured to temporarily secure the control member 25 in a desired position, although it is not necessary. As shown in Figure 2, the illustrated locking mechanism 27 includes a plurality of protrusions that are spaced apart along an internal surface of the slot 24. The control member 25 frictionally engages the projections to maintain the control member 25 in the desired position. Alternatively, the locking mechanism 27 may be a threaded fastener, a pivot latch, a release button, or any other mechanism that is configured to secure the control member 25 in a desired position.

Referring now to Figures 1-3, the illustrated catheter device 10 also includes a catheter tube 30 that extends from the handle assembly 20. The catheter tube 30 is an elongated, flexible member having a proximal end that it is secured to handle assembly 20 and a distal end extending therefrom. Catheter tube 30 can be made of any biocompatible material including, but not limited to, polyvinyl, polyethylene, nitinol, or stainless steel. In addition, the catheter tube 30 can have any diameter, length, or outer wall thickness.

As shown in Figure 2, the proximal end of catheter tube 30 is secured to handle body 21 and communicates with internal cavity 22 through passage 23. Catheter tube 30 can be attached to handle body 21 using a flanged connection, a cast connection, an adhesive, a snap connection, a threaded connection or any other means of fastening. Alternatively, the catheter tube 30 can be attached to the handle body 21 using a connector or any other type of attachment device.

As shown in Figures 1 and 3, an expandable portion 32 is provided at the distal end of catheter tube 30. The illustrated expandable portion 32 is a cylindrical member having a longitudinal axis. The expandable portion 32 can be made of a generally elastic material that can flex between various positions, such as polyvinyl, polyethylene, nitinol, or stainless steel. The expandable portion 32 can be secured to the catheter tube 30 in any way, including, but not limited to, a cast connection, an adhesive, a snap-fit connection, a threaded connection, or any other means of attachment. Alternatively, the expandable portion 32 may be integrally formed from the catheter tube 30. In addition, the expandable portion 32 can have any outer diameter, length, or wall thickness.

The illustrated expandable portion 32 has a pair of struts 34A and 34B. The illustrated struts 34A and 34B are separated by a pair of longitudinally extending slots 35A and 35B that extend through the side walls of the expandable portion 32. As shown in Figure 4, the grooves 35A and 35B are equally spaced from each other around the circumference of the expandable portion 32 so that the struts 34A and 34B have the same circumferential widths, although this is not necessary. Struts 34A and 34B can be of any length, circumferential width, or cross-sectional shape as desired.

As shown in Figures 3 and 4, the illustrated expandable portion 32 also includes a pair of scoring elements 36 that are respectively provided along the outer surfaces of struts 34A and 34B. The incision elements 36 may be atherosclerotic or other incision members having arcuately shaped sharp edges, for example, which are configured to create incisions in atherosclerotic material as will be explained below. The illustrated incision elements 36 extend parallel to the longitudinal axis of the expandable portion 32 and outwardly in a radial direction therefrom. The incision elements 36 are equally spaced from one another around the circumference of the expandable portion 32. However, the expandable portion 32 can have any number or configuration of scoring elements 36 disposed around its circumference. In addition, the scoring elements 36 can have any transverse shape, longitudinal length, or height and can be made of any suitable material including, but not limited to, mild steel, stainless steel, high carbon steel, or ceramic. The scoring elements 36 can be molded with the struts 34A and 34B or can be attached to them in any other way, such as, for example, using a soldered or brazed connection, an adhesive, or any other fastening means.

The distal end of the expandable portion 32 may optionally include a tip member 38. The illustrated tip member 38 has a generally conical shape that facilitates insertion of catheter tube 30 into a blood vessel 50 (see Figures 3 and 4) and subsequent movement through it. However, the tip member 38 can have any desired shape. An opening may extend axially through the tip member 38, the purpose of which will be explained below. The tip member 38 may be integrally formed with the expandable portion 32 or may be attached thereto, as with an adhesive or the like. In addition, the tip member 38 can be made of any biocompatible material including, but not limited to, polyvinyl, polyethylene, nitinol, stainless steel, or polyether block amide.

As shown in Figures 2-4, the illustrated catheter device 10 also includes an inner sleeve 40, although it is not necessary. Inner sleeve 40 is a flexible tubular member that is supported for sliding movement within catheter tube 30, the purpose of which will be explained below. The inner sleeve 40 can be made of any biocompatible material including, but not limited to, polyvinyl, polyethylene, nitinol, stainless steel, or a woven material. In addition, the inner sleeve 40 can have any outer diameter, length, or wall thickness. The inner sleeve 40 need not be a tubular member, but may alternatively be a solid wire, a braided wire, or the like.

As shown in Figure 2, a proximal end of the inner sleeve 40 extends from the catheter tube 30 and into the inner chamber 22 of the handle body 21. The proximal end of the inner sleeve 40 is attached to the base portion 26 of the control member 25 for sliding movement therewith, the purpose of which will be explained below. The inner sleeve 40 may be attached to the base portion 26 by a flanged connection, a cast connection, an adhesive, a threaded connection, or any other means of attachment.

As shown in FIG. 3, the inner sleeve 40 extends the entire length of the catheter tube 30. A distal end of inner sleeve 40 that is opposite handle assembly 20 is secured to tip member 38, which in turn is secured to expandable portion 32. The inner sleeve 40 may be attached to the tip member 38 in any manner, including, but not limited to, a cast connection, an adhesive, a fastener, or the like.

Returning to Figures 1 and 2, the illustrated catheter device 10 also includes a protective sheath 42 that is supported for sliding motion along an outer surface of the catheter tube 30, although it is not necessary. Protective sheath 42 can be made from any biocompatible material including, but not limited to, polyvinyl, polyethylene, nitinol, or stainless steel. In addition, the protective sleeve 42 can have any outer diameter, length, or wall thickness. The purpose of the protective sleeve 42 will be explained below.

The illustrated protective sheath 42 includes a flange 44 that facilitates sliding movement of the protective sheath 42 relative to the catheter tube 30. The illustrated flange 44 is an annular member that is located at one end of the protective sleeve 42 closest to the handle assembly 20. The flange 44 may be integrally formed with the protective sleeve 42 or can be attached thereto in any other way, such as with an adhesive or similar. It should be appreciated that the flange 44 may be of any shape or, alternatively, it may be configured in any manner to perform the functions described herein and below.

The operation of the catheter device 10 will now be described with reference to Figures 1 to 7. With reference initially to Figures 1 to 4, the catheter device 10 is illustrated in a first mode of operation. In the first mode of operation, the control member 25 on the handle assembly 20 is located in the forward position relative to the handle body 21. The inner sleeve 40 extends fully into the catheter tube 30 so that the portion Expandable 32 is in a closed position, as shown in Figures 3 and 4. In the closed position, struts 34A and 34B are generally parallel to each other and to inner sleeve 40. The slots 35A and 35B (illustrated by the broken lines in Figure 3) remain in a generally closed configuration. As such, the expandable portion 32 defines an initial diameter D1, which is generally the same diameter as the remaining length of the catheter tube 30. The initial diameter D1 of the expandable portion 32 can, however, have any desired dimension.

When the catheter device 10 is in the first mode of operation, the distal end of the catheter tube 30 can be percutaneously inserted into a blood vessel 50, as shown in Figures 3 and 4. The illustrated catheter tube 30 is advanced then through the blood vessel 50 along a guide wire 52, which extends through the catheter device 10. For example, guide wire 52 may extend completely through inner sleeve 40, into inner chamber 22 of handle body 21, and exit at a rear end of handle assembly 20 (see FIG. 2). Catheter tube 30 is advanced along guidewire 52 until expandable portion 32 is positioned in a narrow region of blood vessel 50 caused by atherosclerotic material 54. Alternatively, catheter tube 30 may be inserted into blood vessel 50 and guided through it by a delivery catheter (not shown) or any other suitable procedure. During insertion and advancement of catheter tube 30 through blood vessel 50, optional protective sheath 42 is preferably positioned over expandable portion 32, thereby preventing incision elements 36 from contacting the inner walls of vessel 50. blood.

Once the expandable portion 32 is positioned in the narrow region of the blood vessel 50, the incision elements 36 can be exposed by sliding the protective sheath 42 rearward from the distal end of the catheter tube 30, as indicated by the directional arrows. in Figure 3. The illustrated protective sleeve 42 can be moved in this manner by pulling the flange 44 toward the handle assembly 20, which is indicated by the directional arrows in the figure. Referring now to Figures 5-7, catheter device 10 is illustrated in a second mode of operation. To achieve the second mode of operation, the control member 25 moves from the forward position to the rearward position, as indicated by the direction arrow in Figure 5. As the control member 25 moves to the rear position rearwardly, the inner sleeve 40 is inserted into the catheter tube 30, thus reducing the relative length of the inner sleeve 40 with respect to the catheter tube 30. The distal end of inner sleeve 40 is attached to tip member 38, as described above, causing expandable portion 32 to axially compress between tip member 38 and the distal end of catheter tube 30. As a result, struts 34A and 34B bow or expand outwardly in a generally bowed manner thus defining an open position. In the open position, the expandable portion 32 defines a second diameter D2 that is greater than the initial diameter D1 when the expandable portion 32 is in the closed position. As shown in Figure 6, the scoring elements 36 are respectively positioned along most of the radially outer surfaces of the struts 34A and 34B. Furthermore, most of the outer surfaces of the struts 34A and 34B can define a generally flat portion along their length in the open position, the purpose of which will be explained below, although it is not necessary. It should be appreciated that the struts 34A and 34B can be of any length so that the expandable portion 32 can achieve a desired second overall diameter D2 in the open position.

During operation of the catheter device 10, the second diameter D2 can be increased or decreased by selectively moving the control member 25 between the forward and backward positions. For example, a larger second diameter D2 can be achieved by moving the control member 25 further to the rearward position. Conversely, a smaller second diameter D2 can be achieved by moving the control member 25 further towards the forward position. The visual indicator 24A can be used to identify the second instantaneous diameter D2 of the expandable portion 32. Alternatively (or in addition), struts 34A and 34B may be depressed in the open position to automatically expand outward to second diameter D2 when protective sleeve 42 is slid rearward from expandable portion 32. As such, the sliding movement of the protective sleeve 42 relative to the struts 34A and 34B can be used to selectively control the second diameter D2. In this configuration, the inner sleeve 40 and the moving components of the handle assembly 20 may not be necessary.

When the catheter device 10 is in the second mode of operation, the expandable portion 32 can be pulled along the guidewire 52 through the narrow region of the blood vessel 50. This can be accomplished by pulling on the handle assembly 20. In doing so, the incision elements 36 engage the atherosclerotic material 54 and create longitudinal incisions 56 therein. As shown in Figures 6 and 7, the outer surface area of arcuately shaped struts 34A and 34B, which is adjacent to incision member 36, is configured to travel along a surface of atherosclerotic material 54, thus limiting the depth of the incisions 56 and preventing the incision members 36 from cutting into the walls of the blood vessel 50. The expandable portion 32 can be moved any distance along the guidewire 52 to create incisions 56 having any desired length. After the incisions 56 are made in the atherosclerotic material 54, the catheter device 10 can be returned to the first mode of operation (shown in Figures 1 to 4) by moving the control member 25 to the forward position. In doing so, the expandable portion 32 returns to the closed position. The protective sheath 42 can be slid over the expandable portion 32 and the catheter tube 30 can be removed from the blood vessel 50.

Alternatively, the catheter device 10 can be used to create additional incisions 56 in the atherosclerotic material 54. For example, after the catheter device 10 has returned to the first mode of operation, the expandable portion 32 can be relocated within the narrow region of the blood vessel 50. Catheter tube 30 can then be rotated within blood vessel 50 by rotating handle assembly 20 to align incision elements 36 with other portions of atherosclerotic material 54. The above steps can then be repeated any number of times to make multiple passes through the narrow region of the blood vessel 50 and create additional incisions in the atherosclerotic material 54.

Thus, it should be appreciated that the illustrated catheter device 10 is advantageous in many respects. In one example, the second diameter D2 of the expandable portion 32 can be selectively controlled by the operation of the handle assembly 20 or by the sliding movement of the protective sleeve 42. This allows the catheter device 10 to be adapted for use in blood vessels 50 of different sizes or varying diameters. In another example, the illustrated catheter device 10 can apply varying magnitudes of radial forces to atherosclerotic material 54 by controlling the amount of force that is applied to control member 25 in handle assembly 20. This allows catheter device 10 to generate sufficient radial force to create incisions 56 in atherosclerotic material 54 while reducing the potential for tearing the walls of blood vessel 50. In yet another example, catheter device 10 can be used to make any number of passes during a single procedure to make multiple incisions 56 in atherosclerotic material 54 of different lengths and shapes.

Referring now to Figures 8-10, there is illustrated a catheter tube 130 having an expandable portion 132, in accordance with a second embodiment of this invention. Catheter tube 130 and expandable portion 132 may include any structural features described and illustrated above in the above embodiment, although they are not required. Similar features have been numbered with common reference numbers, but have been increased by 100 (ie, 110, 120, 130, etc.). It should be appreciated that similar features are structured similarly, they operate similarly and / or have the same function unless otherwise indicated in the drawings or this specification.

For example, catheter tube 130 may extend from a handle assembly (not shown) as previously described in the first embodiment. The expandable portion 132 is provided at a distal end of the catheter tube 130 and may include a tip member 138. The catheter tube 130 may also include an inner sleeve 140 and a protective sheath (not shown), which is also described above in the first embodiment.

In the illustrated embodiment, however, the expandable portion 132 includes four struts 134A, 134B, 134C, and 134D that are separated respectively by four longitudinally extending slots 135A, 135B, 135C, and 135D. The illustrated struts 134A, 134B, 134C, and 134D each include an incision element 136, although this is not necessary. It should be appreciated that the expandable portion 132 can have any number or configuration of struts and incision elements as desired.

As shown in FIG. 8, the illustrated expandable portion 132 further includes recessed portions 160 that respectively extend toward the outer surfaces of struts 134A, 134B, 134C, and 134D. For example, the struts 134A, 134B, 134C, and 134D may bow slightly inward toward the inner sleeve 140 when in the closed position or, alternatively, may have a reduced thickness along a central portion thereof to create the portions. 160 lowered. The illustrated incision elements 136 are respectively disposed within the recessed portions 160. Thus, when catheter tube 130 is inserted into a blood vessel, as described above, the recessed portions 160 help prevent incision elements 136 from contacting the inner walls of the blood vessel. On the other hand, when the expandable portion 132 is expanded to an open position, as explained below, the scoring elements 136 are exposed from the recessed portions 160. It should be appreciated that the recessed portions 160 can eliminate or reduce the need for the protective sheath (not shown). Guide wire 152 can extend through the entire device.

The expandable portion 132 can be operated between a closed position (shown in Figure 8) and an open position (shown in Figures 9 and 10) by selective movement of the inner sleeve 140 relative to the catheter tube 130, as described. above in the first embodiment. Alternatively (or in addition), struts 134A, 134B, 134C, and 134D can be deflected in the open position. In such an embodiment, the protective sleeve (not shown) can be used to effect movement of the expandable portion 132 between the closed position and the open position.

Referring now to Figures 11 through 13, a catheter tube 230 is illustrated having an expandable portion 232. Catheter tube 230 and expandable portion 232 may include any structural features previously described and illustrated in the above embodiments, although they are not required. Similar features have been numbered with common reference numbers but have been increased by 200 (ie 210, 220, 230, etc.). It should be appreciated that similar features are similarly structured, operate similarly, and / or have the same function unless otherwise indicated in the drawings or this specification.

For example, catheter tube 230 may extend from a handle assembly (not shown) as described above in the first embodiment. The expandable portion 232 is provided at a distal end of the catheter tube 230 and includes a pair of struts 234A and 234B that are separated by a pair of longitudinally extending slots 235A and 235B. Catheter tube 230 may also include a tip member 238, an inner sleeve 240, and a protective sheath (not shown), which is described above in the first embodiment. Guide wire 252 can extend through the entire device.

In the illustrated embodiment, however, the expandable portion 132 includes a first pair of weakened regions 237A, 237B and a second pair of weakened regions 239A, 239B that are respectively located at opposite ends of struts 234A and 234B. The illustrated weakened regions 237A, 237B and 239A, 239B are formed by enlarged openings that extend through the side walls of the expandable portion 132 that function as hinges. The weakened regions 237A, 237B, and 239A, 239b can help reduce the amount of bending stress in the side walls of the expandable portion 132 when the struts 234A and 234B are moved to an open position. Struts 234A and 234B can include any number or configuration of weakened regions. Furthermore, it should be appreciated that any of the other embodiments in this disclosure may also include weakened 237A, 237B and 239A, 239B regions.

The illustrated struts 234A and 234B remain generally flat along their respective lengths both in a closed position (shown in Figure 11) and in an open position (shown in Figures 12 and 13) to form a vertex, although they are not requires such configuration. The scoring elements 236 are provided along the generally flat portion of the respective struts 234A and 234B. As such, the scoring elements 236 can also function as reinforcing elements to increase the strength of the struts 234A and 234B. Additionally, this configuration can reduce the amount of stress in the connection between the scoring elements 236 and the struts 234A and 234B, which may otherwise be caused by bowing of the struts 234A and 234B.

As shown in FIG. 12, the end portions of the scoring elements 236 may extend beyond the apex that is formed by each of the respective struts 234A and 234B. This configuration can increase the effective height of the incision elements 236 when the expandable portion 232 is in the open position. As such, the incision elements 236 may have a reduced height when the expandable portion 232 is in the closed position, which can eliminate the need for the protective sheath (not shown).

The expandable portion 132 can be operated between the closed position and the open position by selective movement of the inner sleeve 240 relative to the catheter tube 230, as previously described in the first embodiment. Alternatively (or in addition), struts 234A and 234B can be deflected in the open position. In such an embodiment, the protective sleeve (not shown) can be used to effect movement of the expandable portion 232 between the closed position and the open position.

Referring now to Figures 14-16, a catheter tube 330 having an expandable portion 332 is illustrated. Catheter tube 330 and expandable portion 332 may include any structural features previously described and illustrated in the above embodiments, although they are not required. Similar features have been numbered with common reference numbers but have been increased by 300 (ie 310, 320, 330, etc.). It should be appreciated that similar features are similarly structured, operate similarly, and / or have the same function unless otherwise indicated in the drawings or this specification.

For example, catheter tube 330 may extend from a handle assembly (not shown) as described above in the first embodiment. The expandable portion 332 is provided at a distal end of the catheter tube 330 and may include a tip member 338. Catheter tube 330 may also include an inner sleeve 340 that is attached to tip member 338 and a protective sheath (not shown), which is also described above in the first embodiment. Guide wire 352 can extend through the entire device.

In the illustrated embodiment, however, the expandable portion 332 includes a pair of struts 334A and 334B that are cantilevered thereon (i.e., not attached to each other or to the tip member 338 at their distal ends), the purpose of which is to will explain below. Struts 334A and 334B are separated by a pair of longitudinally extending slots 335A and 335B that extend from the end of expandable portion 332. A pair of scoring elements 336 are provided respectively along the outer surfaces of struts 334A and 334B. It should be appreciated, however, that the expandable portion 332 may have any number or configuration of struts and incision elements as desired.

As shown in Figures 15 and 16, the illustrated struts 334A and 334B are supported in the expandable portion 332 so that they can be opened in a Y-shaped configuration. For example, the struts 334A and 334B can be opened by stretching the sleeve 340 inside the catheter tube 330, as previously described in the first embodiment. In doing so, the tip member 338 slides along the inner surfaces of the struts 334A and 334B and pivots outwardly. Alternatively (or in addition), struts 334A and 334B can be deflected in the extended open position. In such an embodiment, the protective sleeve (not shown) can be used to effect movement of the expandable portion 332 between a closed position and the extended open position.

Struts 334A and 334B remain generally flat along their respective lengths in both a closed position (shown in Figure 14) and in the extended open position, although this is not necessary. As such, the scoring elements 336 can also function as reinforcing members to increase the strength of the struts 334A and 334B. Additionally, this configuration can reduce the amount of stress in the connection between the scoring elements 336 and the struts 334A and 334B, which may otherwise be caused by bowing of the struts 334A and 334B.

As shown in FIG. 15, the end portions of the incision elements 336 may extend beyond the distal ends of the respective struts 334A and 334B. This configuration can increase the effective height of the incision elements 336 when the expandable portion 332 is in the extended open position. As such, the incision elements 336 may have a reduced height when the expandable portion 332 is in the closed position, which can eliminate the need for the protective sheath (not shown).

Figures 17 and 18 illustrate another example of disclosure. Specifically, Figure 17 illustrates the device of Figure 8 with an exemplary embolic protection device 90 installed therein, while Figure 18 illustrates the device of Figure 17 with the expandable portion 132 in the open position. The embolic protection device 90 may comprise a basket configured to trap the emboli for subsequent removal from the treatment site.

The basket can surround the outer surface of the struts 134A, 134B, and 134C as well as cover the spaces between the struts 134A, 134B, and 134C when the expandable portion 132 is in both the closed and open position. To accomplish this, the basket may be configured to stretch and deform or it may comprise excess and / or overlapping material when the expandable portion 132 is in the closed position that unfolds when the expandable portion 132 is in the open position.

The basket can also cover the front and / or rear of the expandable portion 132. However, in exemplary embodiments, the basket may be open at the proximal end and attached, sealed, attached, or otherwise adhered to the tip member 138 at the distal end. In this manner, the basket creates an opening at the proximal end and is substantially or partially sealed at the distal end by the combination of the basket, guidewire 152, inner sleeve 140, and struts 134A, 134B, and 134C. As will be explained in greater detail herein, the basket may be composed of a woven material or otherwise comprise a plurality of openings along its side walls. In exemplary embodiments, these openings can be configured to allow blood to flow through them while preventing emboli and other particles of a specified size from moving further. In this way, the blood flow and any embolus or other particles contained therein are forced to enter the opening of the basket at the proximal end and exit only if the material enters through the openings provided in the side walls of the chamber. basket.

In exemplary embodiments, the basket is comprised of a mesh. The mesh can be of any size, shape or configuration. The mesh can be composed of nitinol, polytetrafluoroethylene (PTFE), a metal, a polymer, or the like and can extend over any section or all of the expandable portion 132. The mesh can be woven so that the openings are sized to allow blood (including, for example, without limitation, healthy cells, plasma, and platelets) to flow through, trapping emboli and other particles larger than the openings. provided on the mesh.

The embolic protection device 90 may extend over part or all of the expandable portion 132. In exemplary embodiments, embolic protection device 90 extends substantially over the distal half of expandable portion 132 while incision elements 136 may extend substantially over the proximal half of expandable portion 132. Regardless, an expandable ring 91 may be located on the outer surface of expandable potion 132 and can help to secure and preserve the shape of the basket. The expandable ring 91 may be located substantially in the midline of the expandable portion 132, although any location is contemplated. The expandable ring 91 may be composed of nitinol, PTFE, a metal, a polymer, or the like and may be configured to expand and collapse when the expandable portion is moved between the open and closed positions.

The expandable ring 91 can be configured to match the outer diameter of the expandable portion 132 when the expandable portion 132 is in both the open and closed position and can be configured to fit within the sleeve 42 if one is being used. In exemplary embodiments, the expandable ring 91 can be operated by a telescopic mechanism such that portions of the expandable ring 91 slide on top of each other. In other exemplary embodiments, the expandable ring 91 may be configured to deform by elongating and reorienting at an increased lateral angle so that the expandable ring 91 can be positioned substantially flush with the outer surface of the expandable portion 132, when the expandable portion 132 is in the collapsed position and / or is forced into the sleeve 42.

The expandable ring 91 can provide an attachment point for the basket. For example, but without limitation, in embodiments where the basket is the mesh or other woven material, the mesh can be woven around the expandable ring 91. In other exemplary embodiments, the basket may be welded, welded, adhered, or otherwise attached to the expandable ring 91 and / or directly to the struts 134A, 134B, and 134C or other parts of the intravascular catheter device 10.

In exemplary procedures, the expandable portion 132 can be placed in the closed position and positioned downstream of the treatment area. The expandable portion 132 can be placed in the open position. The embolic protection device 90 can be automatically deployed when the expandable portion 132 is placed in the open position as a basket, and the optional expandable ring 91, if used, can expand when the struts 134A, 134B, and 134C are placed in the open position. and collapsing when struts 134A, 134B, and 134C are placed in the closed position. However, in exemplary embodiments, the expandable ring 91 can move between the closed and open positions independently of the expandable portion 132. For example, but not limited to, the expandable ring 91 may be configured to automatically expand when removed from the sheath 42. Regardless, the expandable portion 132 may then retract along part or all of the treatment area to facilitate fragmentation of atherosclerotic plaque. The expandable portion 132 and embolic protection device 90 can then be placed in the closed position, thereby trapping any trapped plungers in the basket during the procedure. This process can be repeated multiple times in the same treatment area or in multiple treatment areas.

Similarly, Figure 19 illustrates the device of Figure 11 with another example embolic protection device 90 installed therein, while Figure 20 illustrates the device of Figure 19 with the expandable portion 232 in the open position. The embolic protection device 90 may be similar to that shown and described with respect to Figures 17 and 18, and may be operated in a similar manner.

Figures 21 and 22 illustrate another exemplary embodiment of embolic protection device 90. The basket of embolic protection device 90 may be a film or cover having various openings 92 located therein. Any size, shape, number and configuration of apertures 92 is contemplated. In exemplary disclosures, the film or coating is comprised of PTFE, although any material is contemplated. Similarly, the The film or cover may be attached to the expandable ring 91, although it is not necessary. Otherwise, the embolic protection device 90 may be similar to that shown and described with respect to Figures 17-20, and may function in a similar manner.

It is notable that while the embolic protection device 90 is illustrated with respect to the devices of Figures 8-9 and 11-12, it is contemplated that the embolic device 90 may be used with any of the disclosures shown and / or described in this document.

Figures 23-30 illustrate a grating instrument 144, 244, and 344 located in the expandable portion 132, 232, and 332, respectively. The grating instrument 144, 244, and 344 can be placed on any number of struts 134A, 134B, and 134C (or 234A and 234B or 334A and 334B). The grating instrument 144, 244, and 344 may extend the entire length of the strut, an upper, lower, distal, proximal, or other portion thereof. The grating instrument 144, 244, and 344 can be any type of device configured to grate, grind, peel, file, shave, cut, or remove any structure or obstruction in the blood vessel. In exemplary embodiments, grating instrument 144, 244, and 344 may be configured to perform atherectomy on atherosclerotic material 54 located in blood vessel 50 by moving expandable portion 132, 232, and 332 axially through blood vessel 50. However, the grating instrument 144, 244, and 344 can be specifically configured for any particular purpose.

In exemplary embodiments, grating instrument 144, 244, and 344 comprise a series of grid openings located along struts 134A, 134B, and 134C (or 234A and 234B or 334A and 334B). The grate openings can be similar to those used in a cheese or microplane grater, but sized and configured to fit the 134A, 134B, and 134C struts (or 234A and 234B or 334A and 334B) and grate a located substance or obstruction within the blood vessel 50. In exemplary embodiments, the substance or obstruction to be grated is atherosclerotic material 54. The grid openings may contain a first part that is raised or depressed relative to a second part so that the substance or obstruction is removed when the grating instrument 144, 244, and 344 is passed over the surface of the substance or obstruction. For example, but without serving as a limitation, the raised or depressed portion may be an edge of the grate opening or it may be a tab or other protrusion in the grate opening. Additionally, or alternatively, the grid openings may comprise a sharp or rough portion that is configured to remove atherosclerotic material 54 when grating instrument 144, 244, and 344 is passed over its surface.

The grid openings can be of any size or shape. For example, but without limitation, the grid openings can be circular, oval, square, rectangular, or the like. Additionally, the grate openings may be spaced along struts 134A, 134B, and 134C (or 234A and 234B or 334A and 334B) randomly or in any pattern. In exemplary embodiments, the grid openings are formed by punching, stamping, punching, or otherwise cutting them from the otherwise solid struts 134A, 134B, and 134C (or 234A and 234B or 334A and 334B). However, in other exemplary embodiments, the grid openings may be integrally formed with the struts.

The grating instrument 144, 244, and 344 can be configured so that the grid is made when the expandable portion 132, 232, and 332 moves axially through the blood vessel 50 forward or backward. In exemplary embodiments, this can be accomplished by alternating or otherwise varying the location of the relatively raised surface (ie, the first part). Additionally, or alternatively, this may be accomplished by alternating or otherwise varying the location of the sharp or rough portion on the distal or proximal side of the grid opening as appropriate.

In other exemplary embodiments, the grating instrument 144, 244, and 344 can be configured so that the grating is made only when the expandable portion 132, 232, and 332 moves axially through the blood vessel 50 in a particular direction. For example, but without serving as a limitation, the grating instrument 144, 244, and 344 can be configured to grate the atherosclerotic material 54 when the expandable portion 132, 232, and 332 is axially retracted through the blood vessel 50, but is configured not to grating the atherosclerotic material 54 as the expandable portion 132, 232 and 332 is advanced axially through the blood vessel 50. Similarly, the grating instrument 144, 244, and 344 can be configured to grate the atherosclerotic material 54 when the expandable portion 132, 232, and 332 is advanced axially through the blood vessel 50, but is configured not to grate the atherosclerotic material when the expandable part is axially retracted through blood vessel 50.

In exemplary embodiments, this can be accomplished by providing the relatively raised surface (ie, the first portion) on the distal or proximal side of the grid opening, as appropriate. Additionally, or alternatively, this can be achieved by providing the sharp or rough portion on the distal or proximal side of the grid opening, as appropriate. For example, but without serving as a limitation, grating the atherosclerotic material 54 when the expandable portion 132, 232, and 332 is axially retracted through the blood vessel 50, the relatively higher surface (i.e., the first portion), and / or the Sharp or rough part can be provided in the distal part of the openings.

The grating instrument 144, 244, and 344 can be positioned to contact the substance or obstruction to be grated when the expandable portion 132, 232, and 332 is placed in the open position. The grating instrument 144, 244, and 344 can be configured so that it does not come into contact with the vessel wall. 50 or the structure or grid obstruction when the expandable portion 132, 232 and 332 is in the closed position. Regardless, a protective sleeve 42 that is configured to substantially surround and protect the grating instrument 144, 244, and 344 from contact with the surrounding blood vessel 50 or structures or obstructions therein may be used when the expandable portion 132, 232, and 332 it is in the closed position. The expandable portion 132, 232, and 332 may advance to a target zone within the blood vessel 50 and move to the open position so that the grating instrument 144, 244, and 344 contacts the surface of the atherosclerotic material 54. The expandable portion 132, 232, and 332 can then be moved axially through the blood vessel 50 to perform an atherectomy.

Grating instrument 144, 244, and 344 can be used with or without scoring elements 136, 236, and 336. In such embodiments, incision elements 136, 236, and 336 may extend into atherosclerotic material 54, scoring it and facilitating fragmentation of atherosclerotic material 54. Simultaneously, the grating instrument 144, 244, and 344 can be moved along the surface of the atherosclerotic material 54, grating it, and facilitating its removal.

It is contemplated that the grating instrument 144, 244, and 344 may be used with any of the embodiments shown or described herein. In accordance with the invention illustrated in Figures 29 and 30, the grating instrument 144, 244 and 344 is used in combination with the embolic protection device 90, with the incision elements 136, 236 and 336. In this manner, atherosclerotic material 54 grated or otherwise removed by grating instrument 144, 244, and 344 can be captured by embolic protection device 90 and removed from blood vessel 50. In exemplary embodiments, embolic protection device 90 may be sized and configured to capture fragments 54 of atherosclerotic material that would be created based on the size and type of grating or other grating instrument 144, 244, and 344 openings used.

The use of embolic protection device 90 with grating instrument 144, 244, and 344 is not limited to the embodiment shown in FIG. 29 and FIG. 30. It is contemplated that grating instrument 144, 244, and 344, device 90 embolic protection devices and / or incision elements 136, 236 and 336 may be used with any of the embodiments shown and described herein. While the grating instrument 144, 244, and 344 is often described as being used for grating or removing atherosclerotic material 54, those skilled in the art will recognize that the grating instrument 144, 244, and 344 can be used to grate or remove any structure. or localized obstruction in the blood vessel.

The principle and mode of operation of this invention have been explained and illustrated in its preferred embodiments.

Claims (8)

An intravascular catheter device (10) for treating a site of care located within a blood vessel (50) comprising atherosclerotic material (54), said device (10) comprising: a flexible catheter tube (30, 130, 230, 330); a handle assembly (20), wherein the flexible catheter tube (30, 130, 230, 330) extends from the handle assembly (20); an expandable portion (32, 132, 232, 332) secured to a distal end of said catheter tube (30, 130, 230, 330) and comprising a plurality of struts (34A, 34B, 134A, 134B, 134C, 134D , 234A, 234B, 334A, 334B) each defining an outward-facing surface, the expandable portion (32, 132, 232, 332) being operable between a closed position, wherein the portion (32, 132, 232, 332) expandable has a first diameter and an open position, wherein the expandable portion (32, 132, 232, 332) has a second diameter that is greater than the first diameter; an inner sleeve (40, 140, 240, 340) traveling through the flexible catheter tube (30, 130, 230, 330) and in communication with the handle assembly (20), wherein the sleeve (40, 140, 240, 340) interior is configured to move the expandable portion (32, 132, 232, 332) between the open and closed positions; a grating instrument (144, 244, 344) located on at least one of the struts (34A, 34B, 134A, 134B, 134C, 134D, 234A, 234B, 334A, 334B), wherein said grating instrument (144 , 244, 344) comprises a series of grid openings and is configured to remove atherosclerotic material (54) when the expandable portion (32, 132, 232, 332) is placed in the open position and moved axially through the vessel ( 50) blood; an embolic protection device (90) located and configured to surround at least a portion of the outer surface of the expandable portion (32, 132, 232, 332) when the expandable portion (32, 132, 232, 332) is located both in the open as well as the closed position, in which the embolic protection device (90) is configured to capture the fragments of the grated atherosclerotic material (54) by the grating instrument (144, 244, 344); and an incision member (36, 136, 236, 336) provided and extending from the outward facing surface of at least one of the struts (34A, 34B, 134A, 134B, 134C, 134D, 234A, 234B, 334A , 334B), the scoring member (36, 136, 236, 336) has a sharp edge located along an upper edge thereof in which said sharp edge extends substantially parallel to a longitudinal axis of the portion ( 32, 132, 232, 332) expandable when the expandable portion (32, 132, 232, 332) is in the closed position and is configured to mark atherosclerotic material (54) as it moves axially through the blood vessel (50). The intravascular catheter device (10) of claim 1, wherein: Each grid opening comprises a first part that rises with respect to a second part thereof. The intravascular catheter device (10) of claims 1 or 2, wherein: the grid openings comprise a sharp or rough part. The intravascular catheter device (10) of any of claims 1-3 wherein: The grid openings extend substantially over the proximal half of the struts (34A, 34B, 134A, 134B, 134C, 134D, 234A, 234B, 334A, 334B). The intravascular catheter device of any of claims 1-4 wherein: the grating openings extend over most of the struts (34A, 34B, 134A, 134B, 134C, 134D, 234A, 234B, 334A, 334B). The intravascular catheter device (10) of claim 1, wherein: the grating instrument (144, 244, 344) is located in a distal portion of the expandable portion (32, 132, 232, 332); and The embolic protection device (90) is located in a proximal portion of the expandable portion (32, 132, 232, 332). The intravascular catheter device (10) of any of claims 1-6, further comprising: a protective sheath (42) configured to selectively surround the expandable portion (32, 132, 232, 332) and the grating instrument (144, 244, 344) when the expandable portion (32, 132, 232, 332) is in the closed position. The intravascular catheter device (10) of claim 1, further comprising: a tip member (38, 138, 238, 338) connected to a distal end of the inner sleeve (40, 140, 240, 340) and configured to move the expandable portion (32, 132, 232, 332) between the open position and closed.